Nivolumab, Carboplatin, and Paclitaxel in Treating Patients With Stage III-IV Head and Neck Squam… (NCT03342911) | Clinical Trial Compass
CompletedPhase 2
Nivolumab, Carboplatin, and Paclitaxel in Treating Patients With Stage III-IV Head and Neck Squamous Cell Carcinoma That Can Be Removed by Surgery
United States34 participantsStarted 2017-11-13
Plain-language summary
This phase II trial studies how well nivolumab, carboplatin, and paclitaxel work in treating patients with stage III-IV head and neck squamous cell carcinoma that can be removed by surgery. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab, carboplatin, and paclitaxel may work better in treating patients with head and neck squamous cell carcinoma.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients must be 18 years of age and older.
* Pathologically confirmed SCCHN, not previously treated, with a plan to undergo surgery
* Patients who have stage III-IV disease without distant metastases (M0) of 1) oral cavity, 2) larynx, 3) hypopharynx 4) oropharynx (human papillomavirus \[HPV\] neg) using American Joint Committee on Cancer (AJCC) 8th edition
* Patients who have oropharyngeal cancer that HPV positive, stage II-III disease without distant metastases (M0) using AJCC 8th edition
* All patients with oropharyngeal SCCHN must be tested for HPV (by p16 and/or HPV in situ hybridization \[ISH\] or polymerase chain reaction \[PCR\])
* Patients must be evaluated by a head and neck surgeon and be deemed surgically resectable at baseline
* Tumor sample must be available for HPV p16 and PD-L1 testing and if oropharyngeal, must be tested for HPV p16
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* While blood cells 2000/ul or more
* Absolute neutrophil count 1500/ul or more
* Platelets 100,000/ul or more
* Hemoglobin 9 g/dl or more; (transfusion permitted)
* Bilirubin less than or equal to 1.5 x the upper limit of normal (except subjects with Gilbert syndrome, who can have total bilirubin \< 3 mg/dl)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3 x the upper limit of normal
* Glomerular filtration rate (GFR) greater than or equal to 40 ml/min using the Cockcroft-Gault formula or serum cr…
What they're measuring
1
Pathologic Complete Response Rate
Timeframe: Up to 26 months
Trial details
NCT IDNCT03342911
SponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University